Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-22 @ 7:26 AM
Study NCT ID:
NCT04517968
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant With Cusomized Healing Abutment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in bone density', 'timeFrame': 'at 3rd, 6th months', 'description': 'Cone beam CT will be taken immediately and 6 months postoperatively On Demand 3d software\\*\\* is used to assess:\n\n1. Crestal bone loss.\n2. Perapical Bone density.'}], 'secondaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': '1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months', 'description': 'The patients will be examined using the Visual Analogue Scale (VAS). the scale is from 0-10 0 =no pain 10= most severe pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-implant Osteogensis']}, 'descriptionModule': {'briefSummary': 'evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.', 'detailedDescription': 'Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.\n\nThe aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.\n\nA clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age range: 20 - 40 years\n* Good oral hygiene\n* A freshly extracted socket in the mandibular molar area.\n* The gap between the implant and the bone will be at least 3-4 mm.\n\nExclusion criteria:\n\n* Acute infection (periodontitis or mucosal infection)\n* Patients on radiotherapy or chemotherapy.\n* Alcohol or drug abuse.\n* Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)\n* Smokers.\n* Parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT04517968', 'briefTitle': 'Immediate Implant With Cusomized Healing Abutment', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)', 'orgStudyIdInfo': {'id': 'Immediate implants'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate implant with customized healing abutment', 'interventionNames': ['Other: immediate implant with customized healing abutment']}], 'interventions': [{'name': 'immediate implant with customized healing abutment', 'type': 'OTHER', 'description': "* All patients will be operated under local anesthesia.\n* Atraumatic extraction of the remaining root or tooth will be achieved.\n* A careful curettage of the socket will be performed if any granulation tissue is present.\n* Sequential drilling of the osteotomy site with copious irrigation will be done\n* The Implant is secured in place using a torque wrench.\n* Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket.\n* Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends.\n* The abutment will be attached to the implant.", 'armGroupLabels': ['immediate implant with customized healing abutment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21526', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}